K953870 is an FDA 510(k) clearance for the ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS. This device is classified as a Timer, Clot, Automated (Class II - Special Controls, product code GKN).
Submitted by Medtronic Vascular (Parker, US). The FDA issued a Cleared decision on October 31, 1995, 75 days after receiving the submission on August 17, 1995.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5400.
| 510(k) Number | K953870 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1995 |
| Decision Date | October 31, 1995 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKN — Timer, Clot, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5400 |